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Each formulation is unique, just as each drug candidate is unique. At Pharmatek, formulation projects start with a strategic formulation plan. The formulation strategy is the result of a thorough analysis of the preformulation data report, the intended manufacturing process, any patient compliance issues and the strategic goals of the company.
At Pharmatek, the comprehensive evaluation of drug candidates during pre-formulation is critical to the formulation development process. Certain candidates present specific challenges such as low bioavailability, poor solubility and/or permeability and poor physical stability. Formulation development can be helpful in overcoming many of these issues.
Execution of the formulation strategy utilizes a logical, data driven approach:
- Pre-formulation solubility and stability evaluations
- Comprehensive excipient screening
- Prototype development
- Formulation optimization and finalization
- Supporting documentation and data package
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- Parenteral formulations: liquid in a vial, powder in a vial for reconstitution, lyophilized powder for reconstitution
- Oral formulations: solutions, suspensions, emulsions, capsules, tablets, coated capsules or tablets (for non-rodent species)
- Parenteral formulations: liquid in a vial, powder for reconstitution, lyophilized powder for reconstitution
- Oral formulations: powder in a bottle for reconstitution, solutions (aqueous or organic), suspensions, emulsions, SEDDS, taste-masked solutions, neat API in a capsule, liquid filled capsules, semi-solid filled hard shell capsules, formulated capsules, formulated tablets
- Tablet and capsule formulation capabilities: direct blending, dry granulation/roller compaction, wet granulation (bottom or top driven, high or low shear, top-spray fluid bed), melt granulation, multiparticulates, sustained release matrix tablets, amorphous dispersions (spray drying), orally disintegrating tablets
- Tablet, capsule, or multiparticulate coating (pan coating or Wurster fluid bed coating): film/color coating, taste masking, moisture protective coating, enteric/targeted delivery coating, extended/sustained release coating
Note: All formulation development techniques can be applied to both non-potent and highly-potent/cytotoxic compounds
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Formulation development is often seen as a black box. At Pharmatek, it's a science. Our logical, data-driven approach to formulation development gives your compound the best chance at success and provides our clients the most efficient, straightforward process for manufacturing their compound. |
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